K042118 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE EBV IGG TEST SYSTEM. This device is classified as a Antiserum, Fluorescent, Epstein-barr Virus (Class I - General Controls, product code JRY).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on April 29, 2005, 266 days after receiving the submission on August 6, 2004.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K042118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2004 |
| Decision Date | April 29, 2005 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JRY — Antiserum, Fluorescent, Epstein-barr Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |